Z-1394-2017Class II

BD AffirM VPIII Microbial Identification Test

Name: Z-1394-2017 BD AffirM VPIII Microbial Identification Test
Creator: Becton Dickinson & Co.
Published: 2015-08-27
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2015-08-27 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Co. began a recall of BD AffirM VPIII Microbial Identification Test on 2015-08-27. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1394-2017
Classification: Class II
Status: Terminated
Initiated: 2015-08-27
Posted: 2017-02-27
Terminated: 2017-03-06
Recalling firm: Becton Dickinson & Co
Product: BD AffirM VPIII Microbial Identification Test
Product code: MLA Dna Probe, Yeast
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.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: 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.
Quantity in commerce: 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, 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,
Product codes and lots: Catalog Number Batch Number 446252 5126980 5135673 5138774 5140625 5142767 5153674 5153675 5224882 446257 5141655 5148857 5156873 5173648

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1394-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1394-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-08	2017-03-02

Product code MLA

K931374Class IAffirm Vpiii Microbial Identification TestMicroprobe Corp. / cleared 1993-06-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)