CLASS II Device recall · Reported 26 Dec 2018 · FDA Enforcement Report
Staclot¿ LA recalled by Diagnostica Stago
Diagnostica Stago is recalling Staclot¿ LA (, distributed nationwide in the US. The recall was initiated on 14 Nov 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-0610-2019
- FDA event ID
- 81678
- Recalling firm
- Diagnostica Stago, Parsippany, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Nov 2018
- FDA classified
- 14 Dec 2018
- Reported
- 26 Dec 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 14 Nov 2018 | Recall initiated by company | |
| 14 Dec 2018 | Classified by FDA | +30 days |
| 26 Dec 2018 | 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
There have been reports of shortened (T1-T2) results, where some instances of result recovery outside of the range of less than or equal to 15 seconds.
Product as listed by the FDA
Staclot¿ LA (REF 00600) The Staclot¿ LA and Staclot¿ LA 20 test kits are reagent systems designed for the qualitative detection of lupus anticoagulants (LA) in plasma by the use of hexagonal HII phase phospholipid molecules (1, 2).
Where it was distributed
US Nationwide Distribution
Questions about this recall
Is Staclot¿ LA ( recalled?
Yes. Diagnostica Stago recalled Staclot¿ LA ( on 14 Nov 2018. The recall is Class II and its status is Terminated. Recall number Z-0610-2019.
Why was it recalled?
There have been reports of shortened (T1-T2) results, where some instances of result recovery outside of the range of less than or equal to 15 seconds.
Which lots are affected?
Lot #s 251918, 252751
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.
More recalls from Diagnostica Stago
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|---|---|---|---|---|---|
| Device | CLASS II | STA Staclot Protein S recalled by Diagnostica Stago | Diagnostica Stago | Potency & Assay | Nationwide |
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|---|---|---|---|---|---|
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| Device | CLASS II | DxC 500i Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
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| Device | CLASS II | Syva EMIT 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Lead & Heavy Metals | Nationwide |
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