Z-0090-2017Class II

VITROS Chemistry Products LAC Slides, REF/Product Codes 843 3880 (300 slides per sales unit) and 815 0112 (90...

Name: Z-0090-2017 VITROS Chemistry Products LAC Slides, REF/Product Codes 843 3880 (300 slides per sales unit) and 815 0112 (90...
Creator: Ortho-Clinical Diagnostics
Published: 2016-08-11
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2016-08-11 / Terminated

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS Chemistry Products LAC Slides, REF/Product Codes 843 3880 (300 slides per sales unit) and 815 0112 (90 slides per sales unit), Unique Device Identifier... on 2016-08-11. FDA classified it as Class II and gives the reason as "Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen overdose, mucolytic therapy and is used as nutritional supplement, can interfere with VITROS GLU, LAC, TRIG, and URIC...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0090-2017
Classification: Class II
Status: Terminated
Initiated: 2016-08-11
Posted: 2016-10-17
Terminated: 2018-06-11
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Chemistry Products LAC Slides, REF/Product Codes 843 3880 (300 slides per sales unit) and 815 0112 (90 slides per sales unit), Unique Device Identifier Nos. 10758750004911 and 10758750004454, Rx ONLY, IVD --- For in vitro diagnostic use only. VITROS Chemistry Products LAC Slides quantitatively measure lactate (LAC) concentration in plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Product code: KHP Acid, Lactic, Enzymatic Method
Reason for recall: Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen overdose, mucolytic therapy and is used as nutritional supplement, can interfere with VITROS GLU, LAC, TRIG, and URIC Slides assays.
FDA root cause: Under Investigation by firm
Action: Ortho-Clinical Diagnostics sent an URGENT PRODUCT CORRECTION Letter (Ref. CL2016-152) dated August 11, 2016 via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/or US Postal Service Priority Mail (for PO Boxes only) to all customers who could order and use affected product to inform them that new interferant were identified for GLU, LAC, TRIG and URIC Slides which may cause biased results. Foreign affiliates were informed by e-mail on August 11, 2016, of the issue and instructed to notify their consignees of the issue. For questions, please contact our Ortho CareTM Technical Solutions Center at 1-800-421-3311. For questions regarding this recall call 908-218-8776.
Quantity in commerce: US: 32,081 sales units; Foreign: 29,932 sales units
Distribution: Worldwide Distribution - US (Nationwide) Puerto Rico and Bermuda), Internationally to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Poland, Singapore, Spain, and Venezuela.
Product codes and lots: Current/In-date GENs 30, 31

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0090-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0089-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-17
Z-0090-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-17
Z-0091-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-17
Z-0092-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-17

Product code KHP

K955286Class IIEktachem Clinical Chemistry Slide Glucose (Glu)Johnson & Johnson Clinical Diagnostics, Inc. / cleared 1996-05-17

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)