Z-0116-2019Class II

Atellica IM CKMB Calibrator, Cat No. 10995532

Name: Z-0116-2019 Atellica IM CKMB Calibrator, Cat No. 10995532
Creator: Siemens Healthcare Diagnostics, Inc
Published: 2018-07-24
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2018-07-24 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc began a recall of Atellica IM CKMB Calibrator, Cat No. 10995532 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended... on 2018-07-24. FDA classified it as Class II and gives the reason as "A potential bias was identified with certain kits compared to the internal standards". 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-0116-2019
Classification: Class II
Status: Terminated
Initiated: 2018-07-24
Posted: 2018-10-15
Terminated: 2020-05-26
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Atellica IM CKMB Calibrator, Cat No. 10995532 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.
Product code: JHS Differential Rate Kinetic Method, Cpk Or Isoenzymes
Reason for recall: A potential bias was identified with certain kits compared to the internal standards.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On July 24, 2018 Siemens Healthineers issued Urgent Medical Device Recall notices to U.S. customers and Urgent Field Safety Notices to OUS customers. The following are Actions to be Taken by the Customer: Customers using ADVIA Centaur CKMB Calibrator Lots ending in 64: - Review the notice with your Medical Director. - Review your inventory of these products and immediately order replacement ADVIA Centaur CKMB Calibrator kit lots ending in 68 by completing the Field Correction Effectiveness Check Form attached to the letter. - You may continue use of ADVIA Centaur CKMB Calibrator kit lots until replacement product is received in your laboratory. - Upon receipt of replacement product in your laboratory, discontinue use of and discard the ADVIA Centaur CKMB Calibrator kit lots listed in Table 1 of the letter. - ADVIA Centaur CKMB Calibrator kit lots ending in 63 may continue to be used until the assigned expiration date. - Refer to the Additional Information section for expected patient sample bias when transitioning to ADVIA Centaur CKMB Calibrator kit lots ending in 68. Customers using ADVIA Centaur Master Curve Material: - Discontinue use of and discard the ADVIA Centaur MCM lots in Table 1. - Review your inventory of these products and order replacement ADVIA Centaur CKMB Master Curve Material by completing the Field Correction Effectiveness Check Form attached to the letter. - Utilize ADVIA Centaur CKMB MCM Lot 13384 and future lots. - Complete and return the Field Correction Effectiveness Check Form attached to the letter within 30 days. Customers using Atellica IM CKMB Calibrator Lots ending in 66: - Review your inventory of these products and immediately order replacement Atellica IM CKMB Calibrator kit lots ending in 69 by completing the Field Correction Effectiveness Check Form attached to the letter. - You may continue use of Atellica IM CKMB Calibrator kit lots in Table 1 until replacement product is received in your laboratory
Quantity in commerce: 97 kits
Distribution: US Nationwide Distribution
Product codes and lots: SMN 10995532 Lot # Expiry UDI # 57837A66 2018-12-11 (01)00630414598598(10)57837A66(17)20181211 67443A66 2018-12-11 (01)00630414598598(10)67443A66(17)20181211

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0116-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0113-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-24	2018-10-15
Z-0114-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-24	2018-10-15
Z-0115-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-24	2018-10-15
Z-0116-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-24	2018-10-15
Z-0117-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-24	2018-10-15

Product code JHS

K962126Class IIAcs Ckmb II ImmunoassayCiba Corning Diagnostics Corp. / cleared 1996-06-21

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)