FDA Medical Device Recalls (openFDA)
Life Technologies, Corp.: Gibco GlutaMAX Supplement, for In-Vitro Diagnostic Use SKU 35050061
- Recall number
- Z-0174-2019
- Recalling firm
- Life Technologies, Corp.
- Product
- Gibco GlutaMAX Supplement, for In-Vitro Diagnostic Use SKU 35050061
- Status
- Terminated
- Initiated
- 2018-08-24
- Posted
- not on file
- Terminated
- 2020-04-29
- 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 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.
- Quantity
- 1912 units
- Distribution
- Nationwide: Foreign: Argentina Australia Canada China Great Britain Hong Kong India Japan Mexico Netherlands New Zealand Singapore South Korea Taiwan
- Lot, serial or model codes
- Lot Number: 1967697 (UDI 10190302001823) Exp. Date: 30-Jun-2020
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KIT
- Firm FEI
- 1317268
- Firm city
- Grand Island
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28