CLASS II Device recall · Reported 1 Apr 2020 · FDA Enforcement Report
iChemVELOCITY Strips recalled by Beckman Coulter
Beckman Coulter is recalling iChemVELOCITY Strips, distributed in Puerto Rico. The recall was initiated on 17 Feb 2020 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-1535-2020
- FDA event ID
- 85047
- Recalling firm
- Beckman Coulter, Miami, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Feb 2020
- FDA classified
- 20 Mar 2020
- Reported
- 1 Apr 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 17 Feb 2020 | Recall initiated by company | |
| 20 Mar 2020 | Classified by FDA | +32 days |
| 1 Apr 2020 | 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
The Leukocyte and Compensation pads were switched on some vials of lot number 7212269M of the iChem VELOCITY Strips.
Product as listed by the FDA
iChemVELOCITY Strips, Catalog 800-7212
Where it was distributed
Distribution in US including Puerto Rico, Canada, and Taiwan
Questions about this recall
Is iChemVELOCITY Strips recalled?
Yes. Beckman Coulter recalled iChemVELOCITY Strips on 17 Feb 2020. The recall is Class II and its status is Terminated. Recall number Z-1535-2020.
Why was it recalled?
The Leukocyte and Compensation pads were switched on some vials of lot number 7212269M of the iChem VELOCITY Strips.
Which lots are affected?
Catalog 800-7212, UDI 10837461002628; Lot 7212269M
Where was it sold?
Distribution in US including Puerto Rico, Canada, and Taiwan
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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