Z-0770-2021Class II

VITROS Chemistry Products CKMB Slides: (1)VITROS CKMB Slides (60 Slide cartridge)

Name: Z-0770-2021 VITROS Chemistry Products CKMB Slides: (1)VITROS CKMB Slides (60 Slide cartridge)
Creator: Ortho Clinical Diagnostics Inc
Published: 2020-12-11
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2020-12-11 / Open, Classified

FDA source

Ortho Clinical Diagnostics Inc began a recall of VITROS Chemistry Products CKMB Slides: (1)VITROS CKMB Slides (60 Slide cartridge) Product Code:8058232 (2)VITROS CKMB Slides (18 Slide cartridge) Product Code... on 2020-12-11. FDA classified it as Class II and gives the reason as "VITROS Chemistry Products CKMB Slides Potential for Falsely Elevated Results Due to CK-MM Interference". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0770-2021
Classification: Class II
Status: Open, Classified
Initiated: 2020-12-11
Posted: 2021-01-05
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Chemistry Products CKMB Slides: (1)VITROS CKMB Slides (60 Slide cartridge) Product Code:8058232 (2)VITROS CKMB Slides (18 Slide cartridge) Product Code: 8001133 Quantitatively measure creatine kinase MB (CK-MB) activity in serum using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems.
Product code: JHS Differential Rate Kinetic Method, Cpk Or Isoenzymes
Reason for recall: VITROS Chemistry Products CKMB Slides Potential for Falsely Elevated Results Due to CK-MM Interference
FDA root cause: Under Investigation by firm
Action: Ortho Clinical Diagnostics (OCD) issued Urgent Product Correction Notification (CL2020-302) via ORTHO PLUSSM ( e-Communications, on 11 December 2020 to consignees. Letter states reason for recall, health risk and action to take: Per the VITROS CKMB Slides IFU, evaluate the Total CK value of the sample. For the respective CKMB coating, elevated total CK activity (>300 and <1000 U/L) may cause a significantly elevated VITROS CKMB Slides result. If the CK activity exceeds the value listed in the table on page 1, consult with your Medical Director. " Depending on which coating is used in your laboratory, you may want to consider an alternate method for samples with CK activity greater than indicated in the table on page 1. " If your laboratory chooses to discontinue using an affected coating, Ortho will credit your account. Current inventory levels do not allow for replacement. Provide credit quantity information using the Confirmation of Receipt form. " Complete the enclosed Confirmation of Receipt form no later than 22-DEC-2020. Note: complete the form even if your laboratory no longer has inventory of affected product. " Please forward this notification if the product was distributed outside of your facility. A VITROS CKMB Slides coating is currently being manufactured and is expected to be available in the first quarter of 2021. Ortho will continue to perform testing on all future coatings to evaluate CK-MM inhibition and will update the Technical Bulletin as appropriate. If you have further questions, please contact Ortho Care" Technical Solutions Center at 1-800-421-3311. Firm issued Extended Recalls viasent via eComm, FedEx overnight courier and/or US Postal Service Priority Mail (for PO Boxes only) to US consignees (Ortho Direct, Dropship, Distributors and Federal Government): (1) Recall Extension #1, for VITROS CKMB Slides, Coating 0245 (Communication Reference, CL2021-182) On 18 June 2021. (2) Recall Extension #2 for VITROS CKMB Slides, Coating 0246 (Comm
Quantity in commerce: Total= 41,598 U.S. = 403 xU.S. = 41,195; Extended: 25,775 units
Distribution: Worldwide distribution - US Nationwide distribution and the countries of Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Singapore 609917, United Kingdom, France, Germany, Italy, Spain, Portugal, Poland, Russia, Denmark, Norway, Sweden, Belgium, The Netherlands.
Product codes and lots: INITIAL Communication: 11 December 2020, (Communication Ref. # CL2020-302) Coatings 0230, 0231, 0233, 0235, 0239 (all lot numbers) Extended Recalls: Recall Extension #1, for VITROS CKMB Slides, Coating 0245 (Communication Reference, CL2021-182) 18 June 2021 Recall Extension #2 for VITROS CKMB Slides, Coating 0246 (Communication Reference, CL2021-214) 18 August 2021 Recall Extension #3 for VITROS CKMB Slides, Coating 0248 (Communication Reference, CL2021-274) , 1 November 2021 Recall Extension #4 for VITROS CKMB Slides, Coating 0261 (Communication Reference, CL2023-244) , 27 October 2023 UDI: (1) (10758750004294) (2) (10758750004201

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0770-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0770-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-01-13	2021-01-05

Product code JHS

K861387Class IIKodak Ektachem Clinical Chemistry Slides (Ck-Mb)Eastman Kodak Company / cleared 1986-06-27

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)