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

Is my product affected?

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

• UPC 842768018534

Check against the official notice below — it lists the full affected range.

What happened

CSL Behring GmbH recalled Siemens N Latex CDT Kits used for quantitative measurement of carbohydrate-deficient transferrin (CDT) in human serum. The kits were found to produce negative bias in CDT measurements compared to the HPLC method after 15 months based on shelf life monitoring. The recall affected 297 packages distributed in the US (Indiana, Kansas, Missouri, Ohio, and Virginia) and 1,247 packages distributed internationally across multiple countries including Canada, Australia, Mexico, and numerous European and Asian nations.

The affected US lot number is 49822 with UPI 842768018534, and international lot numbers include 49729, 49849, 49985, and 50084, all with an expiration date of April 11, 2020. The source document does not specify what action affected consumers should take regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

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 Distribution: 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 Quantity: 297 PCK US; 1247 PCK OUS Lot/code info: US Lot number: 49822 UDI: 842768018534 OUS: Lot numbers: 49729, 49849, 49985, 50084 Exp. Date: 2020-04-11

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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