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Terminated

Gibco MEM Non-Essential Amino Acids Solution (100X) (SKU 11140050), for In-Vitro Diagnostic Use

FDA Recall Z-0171-2019 · Posted None

Recalling FirmLife Technologies, Corp.
Recall StatusTerminated
Product CodeKIT
Date Initiated2018-08-24
Date Terminated2020-04-29
Product Quantity1329 units

Reason for Recall

Leaky bottles due to a defect in the bottle cap compromising the sterility of the product

Firm Action

Thermo Fisherr issued Urgent Medical Device Recall Notification Letter with a customer response sheet sent to consignees via FedEx on 24-Aug-2018. Consignees have been instructed to discard affected product per local and state requirements, or return the affected product to Thermo Fisher Scientific. All consignees are instructed to complete the attached Customer Response Sheet. Thermo Fisher Scientific will issue a no-cost replacement for the recalled product. In addition, consignees are instructed to review results and laboratory reporting associated with use of the affected product for further action. Consignees should notify any personnel who need to be aware of the potential for failure of performance for this product. Questions: contact Technical Services Department at 800-955-6288 Option 2.

Root Cause

Under Investigation by firm

Distribution Pattern

Nationwide: Foreign: Argentina Australia Canada China Great Britain Hong Kong India Japan Mexico Netherlands New Zealand Singapore South Korea Taiwan

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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