The State Food and Drug Administration issued a recall order: Roche, Beckmann, Siemens...

Recently, the State Drug Administration issued a number of medical device product recall notices, including: BioMérieux France S.
A.
, Siemens Healthineers, Roche Diagnostics (Shanghai) Co.
, Ltd.
, Beckman Coulter International Trading (Shanghai) Co.
, Ltd.
and many other companies
.
BioMerieux’s cytomegalovirus IgM antibody detection kit VIDAS CMV IgM voluntarily recalled On February 28, the website of the State Drug Administration released the bioMerieux France S.
A.
bioMerieux, SA cytomegalovirus IgM antibody detection kit ( Announcement of voluntary recall of VIDAS CMV IgM (CMVM)
.
A few days ago, Merieux Diagnostics (Shanghai) Co.
, Ltd.
reported that due to specific models and specific batches of products, the RFV value of the calibrator was higher than the acceptable range.
The manufacturer bioMerieux France Co.
, Ltd.
bioMerieux, SA Cytovirus IgM antibody detection kit (enzyme-linked immunofluorescence assay) VIDAS CMV IgM (CMVM) (Registration Certificate No.
: National Machinery Injection 20153400764) was voluntarily recalled
.
The recall level is two
.
The recalled product is the cytomegalovirus IgM antibody detection kit (enzyme-linked immunofluorescence method)
.
This product is suitable for in vitro detection of cytomegalovirus IgM antibody in human serum
.
The product registration certificate or filing certificate code is National Machinery Injection 20153400764, the manufacturer is bioMerieux France Co.
, Ltd.
bioMerieux, SA, and the agent is Merieux Diagnostic Products (Shanghai) Co.
,
Ltd.
The regions and countries involved in this recall are global; the recall level is Level 2; the product models and specifications involved are 30 tests/box; the identification information (such as batch number) is 1008873250, 1008988860, 1009095380; the batches involved in product production (or imported into China) are , the quantity is 0 boxes; the sales quantity of the products involved in China is 0 boxes
.
The reason for this recall is that Mérieux France received a complaint and confirmed that the RFV value of the calibrator of the affected batch of products is higher than the acceptable range.
This problem will cause the calibration of the alarm product to be invalid, and the result calculation will not be performed on the patient sample, and there will be no error.
, but may cause a delay in reporting the test results
.
In addition, since the product has been delisted in mainland China in 2020, China is not affected by this action and no corrective action is required
.
Siemens Medical Systems Co.
, Ltd.
voluntarily recalls the ultrasonic diagnostic system On January 28, the website of the National Medical Products Administration reported that Siemens Medical Systems Co.
, Ltd.
reported that there may be potential problems with the products involved: when the ultrasonic system has a disk full error , the clip storage function does not work properly
.
Siemens Medical Systems Co.
, Ltd.
voluntarily recalled its ultrasonic diagnostic system (registration number: National Instrument Injection 20192060016)
.
The recall level is two
.
Roche Diagnostics (Shanghai) Co.
, Ltd.
voluntarily recalled single-use peripheral blood collection needles There is a difference between the time between the expiration date of the English label and the production date and the content of the expiration date in the Chinese manual "[Storage conditions and validity period] Store at room temperature, 4 years"
.
Roche Diagnostics (Shanghai) Co.
, Ltd.
voluntarily recalled the disposable peripheral blood collection needles (registration number: National Machinery Injection 20152220495) it sold
.
The recall level is three
.
Beckman Coulter International Trading (Shanghai) Co.
, Ltd.
voluntarily recalled HLA-B27 detection kit (dry powder flow cytometry method) (Shanghai) Co.
, Ltd.
reported that due to the product involved, a higher concentration of anti-B7 antibody was added to the DuraClone B27 Reagent Kit reagent formulation of the HLA-B27 detection kit (dry powder flow cytometry method)
.
The addition of higher concentrations of B7 antibody may result in non-specific binding of anti-HLA B7 antibody to HLA B27 antigen
.
This may lead to changes in MDFI and may lead to problems such as false negative results, HLA-B27 detection kit (dry powder flow cytometry) produced by Beckman Coulter International Trading (Shanghai) Co.
, Ltd.
(Registration No.
: National Machinery Injection No.
20183400311) voluntarily recalled
.
The recall level is three
.