Z-1152-2013Class II

VITROS Chemistry Products PHBR (Phenobarbital) Slides, REF 822 1384. For the quantitative measure of...

Name: Z-1152-2013 VITROS Chemistry Products PHBR (Phenobarbital) Slides, REF 822 1384. For the quantitative measure of...
Creator: Ortho-Clinical Diagnostics
Published: 2013-03-14
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2013-03-14 / Terminated

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS Chemistry Products PHBR (Phenobarbital) Slides, REF 822 1384. For the quantitative measure of phenobarbital (PHBR) concentration in serum and plasma on 2013-03-14. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1152-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-14
Posted: 2013-04-19
Terminated: 2015-06-23
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Chemistry Products PHBR (Phenobarbital) Slides, REF 822 1384. For the quantitative measure of phenobarbital (PHBR) concentration in serum and plasma.
Product code: DLZ Enzyme Immunoassay, Phenobarbital
Reason for recall: 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.
FDA 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 in commerce: 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.
Product codes and lots: 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.].

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1152-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1152-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-01	2013-04-19

Product code DLZ

K984288Class IIVitros Chemistry Products Phbr SlidesOrtho-Clinical Diagnostics, Inc. / cleared 1999-01-26

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)