FDA Medical Device Recalls (openFDA)
Ortho-Clinical Diagnostics: VITROS Chemistry Products PHBR (Phenobarbital) Slides, REF 822 1384. For the quantitative measure of phenobarbital (PHBR) concentration in serum and plasma.
- Recall number
- Z-1152-2013
- Recalling firm
- Ortho-Clinical Diagnostics
- Product
- VITROS Chemistry Products PHBR (Phenobarbital) Slides, REF 822 1384. For the quantitative measure of phenobarbital (PHBR) concentration in serum and plasma.
- Status
- Terminated
- Initiated
- 2013-03-14
- Posted
- 2013-04-19
- Terminated
- 2015-06-23
- Reason
- Ortho Clinical Diagnostics (OCD) received customer complaints of intermittent imprecision, outliers, or shifts in accuracy and control fluid values outside of expected intervals when using VITROS Chemistry Products PHBR Slides. OCD's investigation confirmed that positively biased values for patient samples could be obtained that may not be detected by quality control fluids.
- Root cause
- Unknown/Undetermined by firm
- Action
- On 3/14/13, URGENT PRODUCT CORRECTION NOTIFICATION letters (dated 3/14/13), Questions & Answers, and Response Forms were sent to consignees via FedEx courier or US Postal Service Priority Mail. Consignees were informed of the issue and advised to immediately discontinue using VITROS PHBR Slides. On 3/14/13, distributor letters were sent via US Postal Service Priority Mail to the distributors. They were advised of the issue and instructed to discontinue distributing and discard their remaining inventory of VITROS PHBR Slides. On 3/14/13, foreign affiliates were informed by e-mail of the issue and instructed to notify their consignees of the issue and actions.
- Quantity
- Domestic: 11,164 units, Foreign: 594 units
- Distribution
- Worldwide Distribution-USA (nationwide) and Puerto Rico and the countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Singapore, Spain, and Venezuela.
- Lot, serial or model codes
- All Lot Numbers containing: GEN 38, Coating No. 0060, Expiration Date Range 03/01/13 through 07/01/13; GEN 39, Coating No. 0062, Expiration Date Range 07/01/13 through 09/01/13; GEN 40, Coating No. 0063, Expiration Date Range 10/01/13 through 12/01/13; GEN 41, Coating No. 0064, Expiration Date Range 12/01/13 through 02/01/14. [A Coating (CTG) is a unique identifier within the Lot Number of some of OCD's products. The term GEN and CTG refer to a specific segments of the reagent lot number. Current lots within expiry were all from Coatings 0060, 0062, 0063 or 0064.].
- 510(k) numbers
- ["K984288"]
- PMA numbers
- not on file
- Product code
- DLZ
- Firm FEI
- 1000136573
- Firm city
- Rochester
- Firm state
- NY
- 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
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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