FDA Medical Device Recalls (openFDA)
Ortho-Clinical Diagnostics: VITROS Chemistry Products PHBR Slides, REF 822 1384 --- COMMON/USUAL NAME: VITROS PHBR (Phenobarbital) Slides --- Ortho-Clinical Diagnostics, Inc. Rochester, NY --- Ortho-Clinical Diagnostics High Wycombe, UK --- This is an in vitro diagnostic. For in vitro diagnostic use only. VITROS Chemistry Products PHBR Slides quantitatively measure Phenobarbital (PHBR) concentration in serum and plasma using VITROS 250/350/950 and 5,1 FS Chemistry Systems and the VITROS 5600 Integrated System.
- Recall number
- Z-1117-2012
- Recalling firm
- Ortho-Clinical Diagnostics
- Product
- VITROS Chemistry Products PHBR Slides, REF 822 1384 --- COMMON/USUAL NAME: VITROS PHBR (Phenobarbital) Slides --- Ortho-Clinical Diagnostics, Inc. Rochester, NY --- Ortho-Clinical Diagnostics High Wycombe, UK --- This is an in vitro diagnostic. For in vitro diagnostic use only. VITROS Chemistry Products PHBR Slides quantitatively measure Phenobarbital (PHBR) concentration in serum and plasma using VITROS 250/350/950 and 5,1 FS Chemistry Systems and the VITROS 5600 Integrated System.
- Status
- Terminated
- Initiated
- 2011-06-23
- Posted
- 2012-02-28
- Terminated
- 2016-05-10
- Reason
- Ortho Clinical Diagnostics (OCD) received customer complaints of intermittent imprecision, outliers, or shifts in control fluid values when using various lots of VITROS Chemistry Products PHBR Slides (Phenobarbital) from Coating 0053.
- Root cause
- Nonconforming Material/Component
- Action
- Ortho Clinical Diagnostics sent an "URGENT PRODUCT CORRECTION NOTIFICATION" letter dated June 23, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue using and discard all remaining lots of the affected product. A Confirmation of Receipt Form was attached so customers may complete and return to the firm. The firm recommends that customers consult with their Laboratory Medical Director and requesting physician to resolve any concerns they may have regarding previously reported results. Contact Customer Technical Services at 1-800-421-3311 for questions regarding this notification.
- Quantity
- Domestic - 2345 sale units, Foreign - 632 sales units
- Distribution
- Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain and Venezuela.
- Lot, serial or model codes
- Lot numbers: 2532-0053-4961 (exp. 2/01/12), 2532-0053-4984 (exp. 2/01/12), 2532-0053-4996 (exp. 3/01/12), 2532-0053-4997 (exp. 3/01/12), 2532-0053-0144 (exp. 3/01/12), 2532-0053-0149 (exp. 3/01/12), 2532-0053-0217 (exp. 3/01/12), 2532-0053-0615 (exp. 4/01/12), 2532-0053-0616 (exp. 4/01/12), 2532-0053-1472 (exp. 5/01/12), 2532-0053-1488 (exp. 5/01/12), 2532-0053-1489 (exp. 5/01/12), 2532-0053-1490 (exp. 5/01/12) [Note the four middle numbers (0053) of the above Lot #s constitute the Coating #].
- 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
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