Recalls / —

—#166579

Product

remel THIOGLYCOLLATE MEDIUM, REF 05152

FDA product code

JSG — Culture Media, Non-Selective And Non-Differential

Device class

Class 1

Medical specialty

Microbiology

Affected lot / code info

Lot number: 258192

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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).

Recalling firm

Firm

Remel Inc

Address

12076 Santa Fe Trail Dr, Lenexa, Kansas 66215-3519

Distribution

Distribution pattern

US, Canada, Singapore

Timeline

Recall initiated

2018-08-13

Terminated

2019-06-18

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #166579. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.