Gibco GlutaMAX Supplement, for In-Vitro Diagnostic Use recallZ-0174-2019 · Life Technologies, Corp. · initiated Aug 24, 2018
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Life Technologies, Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Leaky bottles due to a defect in the bottle cap compromising the sterility of the product
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-0174-2019
- Status
- Terminated
- Initiated by the company
- Aug 24, 2018
- Recalling firm
- Life Technologies, Corp.
- Quantity
- 1912 units
- Product code
- KIT
- Distribution
- Nationwide: Foreign: Argentina Australia Canada China Great Britain Hong Kong India Japan Mexico Netherlands New Zealand Singapore South Korea Taiwan
Product description
Gibco GlutaMAX Supplement, for In-Vitro Diagnostic Use SKU 35050061
Code information (models, lots, serial numbers)
Lot Number: 1967697 (UDI 10190302001823) Exp. Date: 30-Jun-2020
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Sodium Pyruvate (100 mM) 11360070Life Technologies Corporation · MEDIA AND COMPONENTS, SYNTHETIC CELL AND TISSUE CULTURE2 recalls0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 81052).
- Z-0171-2019 · TerminatedGibco MEM Non-Essential Amino Acids Solution (100X) (SKU 11140050), for In-Vitro Diagnostic Use
- Z-0172-2019 · TerminatedGibco DPBS, calcium, magnesium, for In-Vitro Diagnostic Use SKU 14040141
- Z-0173-2019 · TerminatedGibco Sodium Pyruvate (100 mM) SKU 11360070, for In-Vitro Diagnostic Use
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page