CLASS II Device recall · Reported 29 Apr 2020 · FDA Enforcement Report

Siemens N Latex CDT Kit- IVD quantitative determination recalled

CSL Behring is recalling Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient, distributed in Indiana, Kansas, Missouri, Ohio, Virginia. The recall was initiated on 2 Mar 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUS Lot number: 49822 UDI: 842768018534 OUS: Lot numbers: 49729, 49849, 49985, 50084 Exp. Date: 2020-04-11

Quantity recalled297 PCK US; 1247 PCK OUS

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1790-2020
FDA event ID: 85282
Recalling firm: CSL Behring, Marburg, N/A
Classification: Class II
Status: Terminated
Recall initiated: 2 Mar 2020
FDA classified: 23 Apr 2020
Reported: 29 Apr 2020
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

2 Mar 2020	Recall initiated by company
23 Apr 2020	Classified by FDA	+52 days
29 Apr 2020	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Negative bias for the carbohydrate-deficient transferrin (CDT) measurement in comparison to the HPLC method, observed to occur after 15 months based on shelf life monitoring

Product as listed by the FDA

Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum. Siemens Material Number (SMN): 10445997

Where it was distributed

IN, KS, MO, OH, VA Foreign: Australia, Austria, Bangladesh, Belgium, Canada, China Czech Republic, Egypt, Finland, France, Germany, Great Britain, Hungary India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Portugal, Republic Korea, Russia Federation, Slovakia, Slovenia, South Africa, Spain Sweden, Switzerland, Taiwan

Indiana Kansas Missouri Ohio Virginia

Questions about this recall

Is Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient recalled?

Yes. CSL Behring recalled Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient on 2 Mar 2020. The recall is Class II and its status is Terminated. Recall number Z-1790-2020.

Why was it recalled?

Negative bias for the carbohydrate-deficient transferrin (CDT) measurement in comparison to the HPLC method, observed to occur after 15 months based on shelf life monitoring

Which lots are affected?

US Lot number: 49822 UDI: 842768018534 OUS: Lot numbers: 49729, 49849, 49985, 50084 Exp. Date: 2020-04-11

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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