CLASS II Device recall · Reported 15 May 2019 · FDA Enforcement Report
Wash1-Wash solution used prior to Lipase assay on recalled by Medica
Medica is recalling Medica Wash1-Wash solution used prior to Lipase assay on the EasyRA clinical chemistry, distributed nationwide in the US. The recall was initiated on 6 Feb 2019 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-1294-2019
- FDA event ID
- 82217
- Recalling firm
- Medica, Bedford, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Feb 2019
- FDA classified
- 7 May 2019
- Reported
- 15 May 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 6 Feb 2019 | Recall initiated by company | |
| 7 May 2019 | Classified by FDA | +90 days |
| 15 May 2019 | 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
Wash1 solution is ineffective in cleaning dispensing probe of TRIG and LDL reagents that interfere with the Lipase (LIP) assay on the EasyRA clinical chemistry analyzer.
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
Medica Wash1-Wash solution used prior to Lipase assay on the EasyRA clinical chemistry analyzer REF 10680 - Product Usage: For use in washing the probe of the Medica EasyRA Chemistry Analyzer. The wash solution in the wedge is used to prevent interference between certain tests.
Where it was distributed
Worldwide distribution - US Nationwide and countries of IRAQ, FRANCE, INDIA, GEORGIA, GEORGIA, FRANCE GUATEMALA, KENYA, IRAN, ESTONIA.
Questions about this recall
Is Wash1-Wash solution used prior to Lipase assay on the EasyRA clinical chemistry analyzer recalled?
Yes. Medica recalled Wash1-Wash solution used prior to Lipase assay on the EasyRA clinical chemistry analyzer on 6 Feb 2019. The recall is Class II and its status is Terminated. Recall number Z-1294-2019.
Why was it recalled?
Wash1 solution is ineffective in cleaning dispensing probe of TRIG and LDL reagents that interfere with the Lipase (LIP) assay on the EasyRA clinical chemistry analyzer.
Which lots are affected?
Lot #s 18066, 18133, 18235, 18317
Where was it sold?
Worldwide distribution - US Nationwide and countries of IRAQ, FRANCE, INDIA, GEORGIA, GEORGIA, FRANCE GUATEMALA, KENYA, IRAN, ESTONIA.
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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