BD AffirM VPIII Microbial Identification Test
FDA device recall Z-1394-2017 · posted 2017-02-27 · Terminated
Recall details
- Recalling firm
- Becton Dickinson & Co.
- 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.
- Action taken
- Becton Dickinson sent an Urgent Product Recall Letter dated August 2015. The distributors were provided with a written communication via email and customers were provided with a written communication via UPS. Customers were not asked to send product back. If further assistance is needed regarding replacements, please contact BD Customer Service Department at 1-800-675-0908. For all other inquiries, please contact BD Technical Services Department at 1-800-638-8663. For further questions please call (410) 316-4428.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- MLA
- Quantity affected
- Qty Distributed to Field - 4,502
- Distribution
- 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,
- Date initiated
- 2015-08-27
- Date posted
- 2017-02-27
- Date terminated
- 2017-03-06
- Location
- Sparks, MD
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AFFIRM VPIII MICROBIAL IDENTIFICATION TEST (K931374) | Microprobe Corp. | 1993-06-15 |