Z-1171-2016Class II

Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro Diagnostic Catalog Number: 506-10: R1...

Name: Z-1171-2016 Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro Diagnostic Catalog Number: 506-10: R1...
Creator: Sekisui Diagnostics P.E.I. Inc.
Published: 2016-01-22
License: https://open.fda.gov/license/

Sekisui Diagnostics P.E.I. Inc. / initiated 2016-01-22 / Terminated / root cause: design

FDA source

Sekisui Diagnostics P.E.I. Inc. began a recall of Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro Diagnostic Catalog Number: 506-10: R1: 1 x 10ml, R2: 2 x 10ml Catalog Number: 506-30... on 2016-01-22. FDA classified it as Class II and gives the reason as "Crystal formation in the Color Reagent (R2) when left on board automated analyzers causing samples to under recover". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1171-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-22
Posted: 2016-03-14
Terminated: 2016-08-09
Recalling firm: Sekisui Diagnostics P.E.I. Inc.
Product: Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro Diagnostic Catalog Number: 506-10: R1: 1 x 10ml, R2: 2 x 10ml Catalog Number: 506-30: R1: 3 x 10ml, R2: 6 x 10ml In-Vitro quantitative measurement of Acetaminophen in serum and plasma used m the diagnosis and treatment of acetaminophen overdose toxicity.
Product code: LDP Colorimetry, Acetaminophen
Reason for recall: Crystal formation in the Color Reagent (R2) when left on board automated analyzers causing samples to under recover
Root cause tag: design
FDA root cause: Device Design
Action: Sekisui sent an Important Field Correction - Customer Notification letter dated January 22, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. 1. Discard all reagent in house with a current expiration date of 2016-09. 2. Update the expiration on all remaining kits on hand with the new expiration dates provided 3. When adding additional reagent to the analyzer, a new reagent wedge should be used. 4. If crystals are observed within reagent stored on-board, reagent should be discarded and replaced with fresh reagent. 5. Complete, sign and return the attached CONFIRMATION OF NOTIFICATION form by FAX to the number provided. This will indicate receipt of this Field Correction, act as confirm action of compliance with the actions,and allow for issuance of replacement material for expired product on hand (lots 47677, 47694, 47695). Questions contact Technical Services at 1-800-565-0265 or via email at [email protected]
Quantity in commerce: 14,407 kits.
Distribution: Worldwide Distribution - US Distribution to the states of : AZ, CA, FL, IA, ID, IL, MA, , MN, MT and ND., and to the countries of Canada, France and Hong Kong.
Product codes and lots: Catalog Number: 506-10 Lot Codes 47677 47694 47649 47650 47662 47663 48253 48385 48386 Catalog Number: 506-30 Lot Codes: 47695 48294

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1171-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1171-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-14

Product code LDP

K081938Class IIAcetaminophen L3k Assay, and Acetaminophen L3k Assay, Models 506-10, 506-30Genzyme Diagnostics P.E.I., Inc. / cleared 2009-05-01

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)