Z-0174-2019Class II

Gibco GlutaMAX Supplement, for In-Vitro Diagnostic Use SKU 35050061

Name: Z-0174-2019 Gibco GlutaMAX Supplement, for In-Vitro Diagnostic Use SKU 35050061
Creator: Life Technologies, Corp.
Published: 2018-08-24
License: https://open.fda.gov/license/

Life Technologies Corporation / initiated 2018-08-24 / Terminated / root cause: sterility

FDA source

Life Technologies, Corp. began a recall of Gibco GlutaMAX Supplement, for In-Vitro Diagnostic Use SKU 35050061 on 2018-08-24. FDA classified it as Class II and gives the reason as "Leaky bottles due to a defect in the bottle cap compromising the sterility of the product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0174-2019
Classification: Class II
Status: Terminated
Initiated: 2018-08-24
Posted: 2018-10-17
Terminated: 2020-04-29
Recalling firm: Life Technologies Corporation
Product: Gibco GlutaMAX Supplement, for In-Vitro Diagnostic Use SKU 35050061
Product code: KIT Media And Components, Synthetic Cell And Tissue Culture
Reason for recall: Leaky bottles due to a defect in the bottle cap compromising the sterility of the product
Root cause tag: sterility
FDA 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 in commerce: 1912 units
Distribution: Nationwide: Foreign: Argentina Australia Canada China Great Britain Hong Kong India Japan Mexico Netherlands New Zealand Singapore South Korea Taiwan
Product codes and lots: Lot Number: 1967697 (UDI 10190302001823) Exp. Date: 30-Jun-2020

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0174-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0171-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-24	2018-10-17
Z-0172-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-24	2018-10-17
Z-0173-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-24	2018-10-17
Z-0174-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-24	2018-10-17

Product code KIT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)