CLASS II Device recall · Reported 6 Jan 2021 · FDA Enforcement Report
BD Phoenix PMIC/ID-108: IVD is intended recalled by Becton Dickinson &
Becton Dickinson & is recalling BD Phoenix PMIC/ID-108: IVD is intended for the in vitro rapid identification (ID) of, distributed nationwide in the US. The recall was initiated on 8 Dec 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-0762-2021
- FDA event ID
- 86963
- Recalling firm
- Becton Dickinson &, Sparks, MD
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Dec 2020
- FDA classified
- 31 Dec 2020
- Reported
- 6 Jan 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Test Kits & Diagnostics
Timeline
| 8 Dec 2020 | Recall initiated by company | |
| 31 Dec 2020 | Classified by FDA | +23 days |
| 6 Jan 2021 | 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
BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aureus could lead to a potential loss of access to a preferred antibiotic regimen and potential reduction in effectiveness of treatment of the infection
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
BD Phoenix PMIC/ID-108: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-positive cocci and gram-positive bacilli Catalog Number: 448608
Where it was distributed
Nationwide
Questions about this recall
Is BD Phoenix PMIC/ID-108: IVD is intended for the in vitro rapid identification (ID) of recalled?
Yes. Becton Dickinson & recalled BD Phoenix PMIC/ID-108: IVD is intended for the in vitro rapid identification (ID) of on 8 Dec 2020. The recall is Class II and its status is Terminated. Recall number Z-0762-2021.
Why was it recalled?
BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aureus could lead to a potential loss of access to a preferred antibiotic regimen and potential reduction in effectiveness of treatment of the infection
Which lots are affected?
All unexpired lots UDI: 00382904486082
Where was it sold?
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 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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