Recall Z-0172-2019 ยท KIT Media And Components, Synthetic Cell And Tissue Culture
Life Technologies, Corp.
Gibco DPBS, calcium, magnesium, for In-Vitro Diagnostic Use SKU 14040141
| Date | Aug 24, 2018 |
| Status | Terminated |
| Reason | Leaky bottles due to a defect in the bottle cap compromising the sterility of the product |
| Root cause | Under Investigation by 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 furt |
| Quantity | 240 units |
| Distribution | Nationwide: Foreign: Argentina Australia Canada China Great Britain Hong Kong India Japan Mexico Netherlands New Zealand Singapore South Korea Taiwan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.