CLASS II Device recall · Reported 7 May 2014 · FDA Enforcement Report
Diagnostic Technologies, LLC recalled by Alfa Wassermann
Alfa Wassermann is recalling Alfa Wassermann Diagnostic Technologies, LLC, distributed nationwide in the US. The recall was initiated on 5 Mar 2014 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-1530-2014
- FDA event ID
- 67897
- Recalling firm
- Alfa Wassermann, West Caldwell, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Mar 2014
- FDA classified
- 29 Apr 2014
- Reported
- 7 May 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 5 Mar 2014 | Recall initiated by company | |
| 29 Apr 2014 | Classified by FDA | +55 days |
| 7 May 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Extremely low absorbance readings.
Product as listed by the FDA
Alfa Wassermann Diagnostic Technologies, LLC. ACE AST Reagent. Product Usage: For quantitative determination of AST in serum and lithium heparin plasma using ACE¿, ACE Alera¿ and ACE Axcel Clinical Chemistry Systems. This test is intended for use in clinical laboratories and physician office laboratories.
Where it was distributed
US Nationwide Distribution
Questions about this recall
Is Diagnostic Technologies, LLC recalled?
Yes. Alfa Wassermann recalled Diagnostic Technologies, LLC on 5 Mar 2014. The recall is Class II and its status is Terminated. Recall number Z-1530-2014.
Why was it recalled?
Extremely low absorbance readings.
Which lots are affected?
ACE¿ AST Reagent Product reorder numbers SA1047 (Lot F3609) and RX1047 (Lot F3610)
Where was it sold?
US Nationwide Distribution
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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