CLASS II Device recall · Reported 24 Oct 2018 · FDA Enforcement Report
Gibco GlutaMAX Supplement, for In-Vitro Diagnostic Use recalled
Life Technologies is recalling Gibco GlutaMAX Supplement, for In-Vitro Diagnostic Use, distributed nationwide in the US. The recall was initiated on 24 Aug 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0174-2019
- FDA event ID
- 81052
- Recalling firm
- Life Technologies, Grand Island, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Aug 2018
- FDA classified
- 17 Oct 2018
- Reported
- 24 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Test Kits & Diagnostics
Timeline
| 24 Aug 2018 | Recall initiated by company | |
| 17 Oct 2018 | Classified by FDA | +54 days |
| 24 Oct 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Leaky bottles due to a defect in the bottle cap compromising the sterility of the product
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Gibco GlutaMAX Supplement, for In-Vitro Diagnostic Use SKU 35050061
Where it was distributed
Nationwide: Foreign: Argentina Australia Canada China Great Britain Hong Kong India Japan Mexico Netherlands New Zealand Singapore South Korea Taiwan
Questions about this recall
Is Gibco GlutaMAX Supplement, for In-Vitro Diagnostic Use recalled?
Yes. Life Technologies recalled Gibco GlutaMAX Supplement, for In-Vitro Diagnostic Use on 24 Aug 2018. The recall is Class II and its status is Terminated. Recall number Z-0174-2019.
Why was it recalled?
Leaky bottles due to a defect in the bottle cap compromising the sterility of the product
Which lots are affected?
Lot Number: 1967697 (UDI 10190302001823) Exp. Date: 30-Jun-2020
Where was it sold?
Nationwide: Foreign: Argentina Australia Canada China Great Britain Hong Kong India Japan Mexico Netherlands New Zealand Singapore South Korea Taiwan
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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