CLASS II Device recall · Reported 6 Jul 2022 · FDA Enforcement Report
TEG 5000 Functional Fibrinogen Reagent recalled by Haemonetics
Haemonetics is recalling TEG 5000 Functional Fibrinogen Reagent, distributed nationwide in the US. The recall was initiated on 26 Apr 2022 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-1310-2022
- FDA event ID
- 90323
- Recalling firm
- Haemonetics, Boston, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Apr 2022
- FDA classified
- 30 Jun 2022
- Reported
- 6 Jul 2022
- Type
- Voluntary: Firm initiated
- Reason category
- Lead & Heavy Metals
- Device type
- Test Kits & Diagnostics
Timeline
| 26 Apr 2022 | Recall initiated by company | |
| 30 Jun 2022 | Classified by FDA | +65 days |
| 6 Jul 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to a shift in the citrated blood reference range for a normal population, the ranges stated in the IFU are changing. If the clinician relies solely on affected results in comparison to the normal donor reference range, it could lead to misdiagnosis and incorrect treatment or failure to treat.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034
Where it was distributed
Domestic distribution US Nationwide.
Questions about this recall
Is TEG 5000 Functional Fibrinogen Reagent recalled?
Yes. Haemonetics recalled TEG 5000 Functional Fibrinogen Reagent on 26 Apr 2022. The recall is Class II and its status is Terminated. Recall number Z-1310-2022.
Why was it recalled?
Due to a shift in the citrated blood reference range for a normal population, the ranges stated in the IFU are changing. If the clinician relies solely on affected results in comparison to the normal donor reference range, it could lead to misdiagnosis and incorrect treatment or failure to treat.
Which lots are affected?
UDI-DI: (01)20812747018095 All lots are affected.
Where was it sold?
Domestic distribution US Nationwide.
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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