Z-1227-2017Class II

N Latex HCY REAGENT, REF/Catalog OPAX03 /SMN 10445973 , IVD

Name: Z-1227-2017 N Latex HCY REAGENT, REF/Catalog OPAX03 /SMN 10445973 , IVD
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2017-01-11
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2017-01-11 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of N Latex HCY REAGENT, REF/Catalog OPAX03 /SMN 10445973 , IVD Product Usage: In-vitro diagnostic reagents for the quantitative determination of total... on 2017-01-11. FDA classified it as Class II and gives the reason as "The firm confirmed a reduced once-opened and on-board stability for N Latex Homocysteine (HCY) OPAX03 lot 802907632 that may result in erroneously reduced or elevated homocysteine values. The stability issue may lead to...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1227-2017
Classification: Class II
Status: Terminated
Initiated: 2017-01-11
Posted: 2017-02-21
Terminated: 2018-06-12
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: N Latex HCY REAGENT, REF/Catalog OPAX03 /SMN 10445973 , IVD Product Usage: In-vitro diagnostic reagents for the quantitative determination of total homocysteine (HCY) in human serum, heparinized plasma and EDTA plasma by means of particle-enhanced immunonephelometry with BN II and BN ProSpec System. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
Product code: LPS Urinary Homocystine (Nonquantitative) Test System
Reason for recall: The firm confirmed a reduced once-opened and on-board stability for N Latex Homocysteine (HCY) OPAX03 lot 802907632 that may result in erroneously reduced or elevated homocysteine values. The stability issue may lead to higher than expected lot-to-lot variation and an impaired product performance.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: URGENT MEDICAL DEVICE RECALL Letter (PP17-005.A.US, dated 1/11/2016) was sent to the sole US consignee via FedEx on 1/11/2017 to notify the customer of the issue. All N Latex HCY OPAX03 lot 802907632 customers are being instructed to discard N Latex HCY OPAX03 lot 802907632. Customers are requested to complete and return the Effectiveness Check questionnaire attached to the UMDR within 30 days. On 1/13/2017, an URGENT MEDICAL DEVICE RECALL letter (PP17-005.B.US, dated 1/13/2017) was sent to the sole US consignee with instructions to discontinue use of and discard the kit lot; complete & return the Field Correction Effectiveness Check/Product Replacement Form attached to this letter within 30 days; Review your inventory of these products to determine your laboratorys replacement needs and to provide information to Siemens for reporting to the authorities. For questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative.
Quantity in commerce: US: 62 kits; Foreign: 290 kits
Distribution: Worldwide Distribution - US Nationwide in the state of Colorado and Foreign distribution to the following countries: Austria, Brazil, Canary Islands, Chile, China, Czech Republic, France, Germany, Great Britain (UK), Italy, Kuwait, Latvia, Poland, Saudi Arabia, Spain, Switzerland, Turkey, United Arab Emirates.
Product codes and lots: Lot 802907632, Exp. 2017-02-13

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1227-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1227-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-01	2017-02-21

Product code LPS

K052788Class IIN Latex Hcy, N Protein Standard Sl, N/t Protein Control L/m/hDade Behring, Inc. / cleared 2006-03-29

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)