CLASS II Device recall · Reported 28 Jan 2015 · FDA Enforcement Report
CD8 (Leu-2a) PE (In vitro diagnostic) recalled
BD Biosciences, Systems & Reagents is recalling CD8 (Leu-2a) PE (In vitro diagnostic), distributed nationwide in the US. The recall was initiated on 19 Dec 2014 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-1000-2015
- FDA event ID
- 70107
- Recalling firm
- BD Biosciences, Systems & Reagents, San Jose, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Dec 2014
- FDA classified
- 20 Jan 2015
- Reported
- 28 Jan 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 19 Dec 2014 | Recall initiated by company | |
| 20 Jan 2015 | Classified by FDA | +32 days |
| 28 Jan 2015 | 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
One lot of CD8 PE is contaminated with CD4 FITC and may cause an unexpected staining pattern and incorrect patient data.
Product as listed by the FDA
CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046. Hematology: Single color direct immunofluorescence reagent for enumerating percentages of mature human suppressor/cytotoxic (CD8+) lymphocytes in erythrocyte-lysed whole blood or peripheral blood mononuclear cell suspensions.
Where it was distributed
Worldwide distribution. US Nationwide including Puerto Rico, China, Brazil, Japan, Guatemala, India, New Zealand, Australia, Canada, Thailand, Chile and Malaysia.
Questions about this recall
Is CD8 (Leu-2a) PE (In vitro diagnostic) recalled?
Yes. BD Biosciences, Systems & Reagents recalled CD8 (Leu-2a) PE (In vitro diagnostic) on 19 Dec 2014. The recall is Class II and its status is Terminated. Recall number Z-1000-2015.
Why was it recalled?
One lot of CD8 PE is contaminated with CD4 FITC and may cause an unexpected staining pattern and incorrect patient data.
Which lots are affected?
Lot number 4220622, Expiry 2016-04-30.
Where was it sold?
Worldwide distribution. US Nationwide including Puerto Rico, China, Brazil, Japan, Guatemala, India, New Zealand, Australia, Canada, Thailand, Chile and Malaysia.
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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