CLASS II Device recall · Reported 7 Jun 2017 · FDA Enforcement Report
Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set recalled
Medtest Holdings is recalling Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set, distributed nationwide in the US. The recall was initiated on 8 Jul 2011 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-2165-2017
- FDA event ID
- 77048
- Recalling firm
- Medtest Holdings, Canton, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Jul 2011
- FDA classified
- 26 May 2017
- Reported
- 7 Jun 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 8 Jul 2011 | Recall initiated by company | |
| 26 May 2017 | Classified by FDA | +2149 days |
| 7 Jun 2017 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set stability claim is not being met.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set Model Number(s): L7572. For the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum.
Where it was distributed
Nationwide
Questions about this recall
Is Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set recalled?
Yes. Medtest Holdings recalled Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set on 8 Jul 2011. The recall is Class II and its status is Terminated. Recall number Z-2165-2017.
Why was it recalled?
Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set stability claim is not being met.
Which lots are affected?
L7572 all configurations
Where was it sold?
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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