FDA Device

remel THIOGLYCOLLATE MEDIUM W/O IND. W/ DEXTROSE W/ HEMIN & VIT.K (a) 10ML, REF 07182 (b) 10ML, REF 07180 (c) 5ML, REF 064732 (d) 5ML, REF 064730 (e) 9ML, REF 064720

Hazard

Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms.

What You Should Do

Remedy

The firm initiated the recall by letter on 08/13/2018. The firm directed the consignee to you inspect their stock and destroy any remaining inventory of the lots listed above and contact Customer Services or your local distributor regarding replacement. They also requested that the consignee review results and laboratory reporting associated with use of the listed lots and consider retesting and/or seek appropriate expert advice for further action. The firm instructed the consignee to further distribute the notice to all who need to be aware within your organization or to any organization where the potentially affected products have been transferred. For questions, please contact Technical Services Department at 800-255-6730 (US) or 913-888-0939 (International).

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Products

remel THIOGLYCOLLATE MEDIUM W/O IND. W/ DEXTROSE W/ HEMIN & VIT.K (a) 10ML, REF 07182 (b) 10ML, REF 07180 (c) 5ML, REF 064732 (d) 5ML, REF 064730 (e) 9ML, REF 064720
Brand
Remel Inc
UPC
(a) 10ML, REF 07182, Lot numbers: 258907, 260413, 258908, 260519 (b) 10ML, REF 07180, Lot numbers: 259526, 258906, 258903, 258904, 258905  (c) 5ML, REF 064732, Lot numbers: 271667, 258182, 259521 (d) 5ML, REF 064730, Lot numbers: 254755, 272020, 260509, 258181, 273564, 258627, 271476, 258629, 271665, 259507, 251146, 272499 (e) 9ML, REF 064720, Lot numbers: 254749, 272497, 251145, 272015, 258183, 258626, 271479, 258625

Units Affected

2730 units

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