Abbott Laboratories Recalls

Similac Probiotic Tri-Blend - 0.017oz (0.50g) packaged in foil packets. 50 foil packets per carton - 3 cartons per case.

Marketed towards preterm infants without approval as a new drug or licensed biologic, as well as unsafe food additive

Zone Perfect Fudge Graham bar 50g bars packaged in foil wrapped- 12 bars individually wrapped per cardboard carton

Potential of foreign material (hard plastic) within product

Pedialyte Unflavored Electrolyte Solution 2 fl oz plastic reclosable bottle 12-4 packs in a case

Compromised seal integrity which could lead to spoilage

Similac 360 Total Care Sensitive with Nipples 2 fl oz reclose able plastic bottle Packaged as: 4 - 6 count carton

Compromised seal integrity which could lead to spoilage

Similac Total Comfort 2 fl oz reclose able plastic bottle Packaged as: 12 - 4 packs in a case, 48 count case

Compromised seal integrity which could lead to spoilage

Similac 360 Total Care 2 fl oz reclose able plastic bottle Packaged as: 6 count carton, 12 count carton, 48 count case

Compromised seal integrity which could lead to spoilage

Similac Stage 1 (Export Colombia) 2 fl oz reclose able plastic bottle Packaged as: 48 count case

Compromised seal integrity which could lead to spoilage

Similac Water - Sterilized (Export Canada) 2 fl oz reclose able plastic bottle Packaged as: 48 count case

Compromised seal integrity which could lead to spoilage

Similac 360 Total Care Sensitive 2 fl oz reclose able plastic bottle Packaged as: 6 count carton, 12 count carton, 48 count case

Compromised seal integrity which could lead to spoilage

Similac Stage 1 (Export Dominican Republic) 2 fl oz reclose able plastic bottle Packaged as: 48 count case

Compromised seal integrity which could lead to spoilage

Similac Neosure 2 fl oz reclose able plastic bottle Packaged as: 48 count case

Compromised seal integrity which could lead to spoilage

Similac Special Care 2 fl oz reclose able plastic bottle Packaged as: 4 count carton

Compromised seal integrity which could lead to spoilage

Similac 360 Total Care/Similac 360 Total Care Sensitive Discharge Kit 2 fl oz reclose able plastic bottle Packaged as: 6 count kit

Compromised seal integrity which could lead to spoilage

Pedialyte Unflavored (Export to Canada) 2 fl oz plastic reclosable bottle 48 count case

Compromised seal integrity which could lead to spoilage

Abbott Jevity Complete, Balanced Nutrition with Fiber Ready to Hang enteral feeding container 1.5 Cal (for tube feeding) 1000 mL 8-33.8 FL OZ (1L) Bottles 270 FL OZ (8L) Liter UPC: 7007462681 62681

Potential leaking/pinholes in bottle

ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27

One lot of reagent was manufactured with insufficient quantities of the heterophilic blocking agents in the conjugate component.

On July 26, 2022, Abbott issued a Product Recall letter for this issue sent the letter via FedEx priority overnight express. The letter provided the reason for the recall and hazard involved and requested the consignee take the following actions: "" IMMEDIATELY discontinue use of ARCHITECT STAT Troponin-I, List Number 2K41-27 lot number 63718UN22 and destroy all inventory of lot 63718UN22 according to your laboratory procedures. " Please contact Customer Support to order replacement material. " Please review this letter with your Medical Director or Laboratory Management and follow your laboratory protocol regarding the need for review of previously reported patient results using lot number 63718UN22. " Complete and return the Customer Reply Form. " If you have forwarded the product listed above to other laboratories, please inform them of this Product Recall and provide to them a copy of this letter. " Please retain this letter for your laboratory records." Questions regarding the information were provided the following contact information: If you or any of the health care providers you serve have questions regarding this information, please contact Customer Service at 1-877-4ABBOTT (available 24 hours a day, 7 days a week).

REF: 4P52-20 Hemoglobin A1c for use with Architect, IVD, CE, R1 1 x 52 mL, R2 1 x 20 mL, A1cDL 2 x 35 mL

There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using the ARCHITECT and Alinity c Hemoglobin A1c assay.

On June 9, 2022, Abbott issued a "Urgent Medical Device Correction" to affected consignees via FedEx. 1. Immediately install the updated assay file versions listed below (as applicable for your laboratory), and manually configure the Low-Linearity value. The assay files can be obtained from www.corelaboratory.abbott 2. For the whole blood application, manually configure the THbWB Low-Linearity to 53.8278. For the hemolysate application, manually configure the THbH Low-Linearity to 1250. For detailed information on editing assay parameters, refer to Changing assay configuration settings, Change a linearity range in the ARCHITECT System Operations Manual, Section 2. 3. Please review this letter with your Medical Director or Laboratory Management and follow your laboratory protocol regarding the need for reviewing previously reported patient results. 4. Complete and return the Customer Reply Form. 5. Please retain this letter for your laboratory records. 6. If you have forwarded the product listed above to other laboratories, please inform them of this Product Correction and provide to them a copy of this letter.

Pedialyte with Immune Support***+Zinc/Selenium & Magnesium***Peach Mango Natural & Artificial Flavor, 33.8 FL OZ (1.05 QT) 1L***INGREDIENTS: WATER, DEXTROSE*** Abbott Nutrition, Abbott Laboratories, Columbus, Ohio 43219-3034 USA

These products are being recalled due to the potential of leakage from the 1L container.

Pedialyte with Immune Support***+Zinc/Selenium & Magnesium***Raspberry Lemonade Natural & Artificial Flavor, 33.8 FL OZ (1.05 QT) 1L*** INGREDIENTS: WATER, DEXTROSE***Abbott Nutrition, Abbott Laboratories, Columbus, Ohio 43219-3034 USA

These products are being recalled due to the potential of leakage from the 1L container.

Pedialyte***Replaces Electrolytes***Great for Kids and Adults***Strawberry Lemonade Natural Flavor with Other Natural Flavor*** 6 0.6 OZ (17g) PACKETS/NET WT. 3.6 OZ (102g)***INGREDIENTS: ANHYDROUSE DEXTROSE, CITRIC ACID, POTASSIUM CITRATE***Manufactured for: Abbott Nutrition, Abbott Laboratories, Columbus, Ohio 43219

The third party contract manufacturer used a dextrose ingredient derived from wheat in one lot of the Strawberry Lemonade powder, which is not declared on the label.