FDA Medical Device Recalls (openFDA)
EMD Chemicals Inc: Anaerotest for microbiology Specification: Performance Test Anerobic: white within 4-6 hours; aerobic: blue with 20 minutes Merck KgaA 64271 Darmstadt, Germany 1.19034.0002 17.08.06 1 unit UPC 4 022536 667928
- Recall number
- Z-0498-2007
- Recalling firm
- EMD Chemicals Inc
- Product
- Anaerotest for microbiology Specification: Performance Test Anerobic: white within 4-6 hours; aerobic: blue with 20 minutes Merck KgaA 64271 Darmstadt, Germany 1.19034.0002 17.08.06 1 unit UPC 4 022536 667928
- Status
- Terminated
- Initiated
- 2006-08-17
- Posted
- 2007-02-17
- Terminated
- 2008-06-06
- Reason
- Lot # OC553145 of Anaerotest failed to remain in specification. QC indicator shows an anaerobic environment even if oxygen is present.
- Root cause
- Other
- Action
- A Recall Letter was issued by EMD Chemicals on 8/17/2006 to discontinue product usage and for product return.
- Quantity
- 8 rolls
- Distribution
- Product was only sent to one US customer: Becton Dickinson, Cayey. Pureto Rico.
- Lot, serial or model codes
- Item number 1.19034.0002 Lot # OC553145
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- J
- Firm FEI
- 2244894
- Firm city
- Gibbstown
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28