CLASS II Device recall · Reported 8 Mar 2017 · FDA Enforcement Report
BD AffirM Vpiii Microbial Identification Test recalled
Becton Dickinson & is recalling BD AffirM Vpiii Microbial Identification Test, distributed nationwide in the US. The recall was initiated on 27 Aug 2015 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-1394-2017
- FDA event ID
- 76492
- Recalling firm
- Becton Dickinson &, Sparks, MD
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Aug 2015
- FDA classified
- 2 Mar 2017
- Reported
- 8 Mar 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 27 Aug 2015 | Recall initiated by company | |
| 2 Mar 2017 | Classified by FDA | +553 days |
| 8 Mar 2017 | 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 has confirmed that a portion of tests associated with the affected lots( 446252 and 446257 ) of product may exhibit blue speckles or fibers on the beads and cards, as shown below. This issue would result in an invalid test, as described in the package insert.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
BD AffirM VPIII Microbial Identification Test
Where it was distributed
Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the states of : AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY and to the countries of : AU, BE, IN, KR, SG,
Nationwide AlabamaArkansasArizonaCaliforniaColoradoConnecticutDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMaine
Questions about this recall
Is BD AffirM Vpiii Microbial Identification Test recalled?
Yes. Becton Dickinson & recalled BD AffirM Vpiii Microbial Identification Test on 27 Aug 2015. The recall is Class II and its status is Terminated. Recall number Z-1394-2017.
Why was it recalled?
BD has confirmed that a portion of tests associated with the affected lots( 446252 and 446257 ) of product may exhibit blue speckles or fibers on the beads and cards, as shown below. This issue would result in an invalid test, as described in the package insert.
Which lots are affected?
Catalog Number Batch Number 446252 5126980 5135673 5138774 5140625 5142767 5153674 5153675 5224882 446257 5141655 5148857 5156873 5173648
Where was it sold?
Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the states of : AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY and to the countries of : AU, BE, IN, KR, SG,
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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