CLASS III Device recall · Reported 12 Feb 2020 · FDA Enforcement Report
Liquid Clinical Chemistry Control recalled by Randox Laboratories
Randox Laboratories is recalling Liquid Clinical Chemistry Control, distributed in New York. The recall was initiated on 13 Dec 2019 and the FDA has classified it as Class III.
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-1100-2020
- FDA event ID
- 84547
- Recalling firm
- Randox Laboratories, Crumlin (North), N/A
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 13 Dec 2019
- FDA classified
- 6 Feb 2020
- Reported
- 12 Feb 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 13 Dec 2019 | Recall initiated by company | |
| 6 Feb 2020 | Classified by FDA | +55 days |
| 12 Feb 2020 | 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
A transcription error has occurred for the Randox Lipase colorimetric value in Liquid Clinical Chemistry Control lot 1021 UE. The target and range are listed as 50 U/L (40 - 60) and should be 72U/L (58 - 86).
Product as listed by the FDA
Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml
Where it was distributed
US: NY and DE OUS: France, Lithuania, Poland, Spain, Switzerland, Turkey, Australia, Hong Kong, Bosnia and Herzegovina, Costa Rica, Ecuador, Gambia, New Zealand and Solomon Islands.
Stores named: Target
Questions about this recall
Is Liquid Clinical Chemistry Control recalled?
Yes. Randox Laboratories recalled Liquid Clinical Chemistry Control on 13 Dec 2019. The recall is Class III and its status is Terminated. Recall number Z-1100-2020.
Why was it recalled?
A transcription error has occurred for the Randox Lipase colorimetric value in Liquid Clinical Chemistry Control lot 1021 UE. The target and range are listed as 50 U/L (40 - 60) and should be 72U/L (58 - 86).
Which lots are affected?
Catalogue Number: LAE4217 GTIN: 05055273208993 Lot Number: 1021UE (EXP: 2020-06-28)
Where was it sold?
US: NY and DE OUS: France, Lithuania, Poland, Spain, Switzerland, Turkey, Australia, Hong Kong, Bosnia and Herzegovina, Costa Rica, Ecuador, Gambia, New Zealand and Solomon Islands.
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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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