CLASS II Device recall · Reported 20 Sep 2017 · FDA Enforcement Report
Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K recalled
Beckman Coulter is recalling Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K, distributed nationwide in the US. The recall was initiated on 20 Jul 2017 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-3118-2017
- FDA event ID
- 77896
- Recalling firm
- Beckman Coulter, Brea, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Jul 2017
- FDA classified
- 12 Sep 2017
- Reported
- 20 Sep 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 20 Jul 2017 | Recall initiated by company | |
| 12 Sep 2017 | Classified by FDA | +54 days |
| 20 Sep 2017 | 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
Reagent carryover from Sekisui ACTH when utilized on the BEC AU 680 analyzer may lead to falsely elevated BEC Lipase recovery exceeding the total precision specification.
Product as listed by the FDA
Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K , Ref. 506-30. The firm names on the label are Sekisui Diagnostics (UK) Limited, United Kingdom, and Sekisui Diagnostics P.E.I. Inc., Canada. Used in laboratory testing.
Where it was distributed
Distribution US nationwide.
Questions about this recall
Why was it recalled?
Reagent carryover from Sekisui ACTH when utilized on the BEC AU 680 analyzer may lead to falsely elevated BEC Lipase recovery exceeding the total precision specification.
Which lots are affected?
All lots
Where was it sold?
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 26 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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