| | Class 2 Device Recall VIDAS CMV IgM 30 Tests |  |
| Date Initiated by Firm | March 16, 2021 |
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| Create Date | April 10, 2021 |
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| Recall Status1 |
Terminated 3 on August 06, 2024 |
| Recall Number | Z-1408-2021 |
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| Recall Event ID |
87555 |
| 510(K)Number | K933549 |
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| Product Classification |
Antibody igm,if, cytomegalovirus virus - Product Code LKQ
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| Product | VIDAS CMV IgM 30 Tests |
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| Code Information |
ref 30205; lot numbers 1008143230 (exp. date: 04 MAY 2021), 1008182270 (exp. date: 26 MAY 2021), 1008363970 (exp. date: 01 SEP 2021), 1008433580 (exp. date: 15 OCT 2021) US ref 30205-01; lot numbers 1008143260 (exp. date: 04 MAY 2021) and 1008363980 (exp. date: 01 SEP 2021) |
Recalling Firm/
Manufacturer |
Biomerieux Inc
595 Anglum Rd
Hazelwood MO 63042-2320
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| For Additional Information Contact | Clinical Customer Support
800-682-2666 |
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Manufacturer Reason
for Recall | bioMerieux received complaints about calibration issue observed on several lots of VIDAS CMV IgM (ref 30205 ; 30205-01). |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| Action | A Recall notification letter titled, "IMPORTANT: URGENT FIELD SAFETY NOTICE" was sent to the to the impacted subsidiaries and distributors on 03/16/2021 via email. The notification includes a Customer Letter to be translated into local language and sent to each impacted customer. The recalling firm requested that the consignees conduct the following actions:
1 - Please distribute this information to all appropriate personnel in their laboratory, retain a copy in their files, and forward this information to all parties that may use this product, including others to whom they may have transferred our product.
2 - Stop using and destroy any stock of lots VIDAS CMV IgM (Ref. 30205 and 30205-01) lots mentioned in Table 1 remaining in their inventory and not already discarded through the Urgent Field Safety notice related to FSCA#5087
3 - Complete the Acknowledgement Form in Attachment A and return it to their local bioMrieux representative to confirm receipt of this notice.
4 - Contact their local customer service if they have any questions. |
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| Quantity in Commerce | 18705 kits |
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| Distribution | Distributed nationwide to NY, CA, IL, WV, NJ, NY, TX, IN, PA, WI, VA, GA, CO, MI, FL, OH, MA, LA, NV, MO, CT and internationally to Argentina, Australia, Belgium, Brazil, Switzerland, Chile, Colombia, Czech Republic, Germany,
Egypt, Spain, France, United Kingdom, Greece, Hong Kong,
Hungary, India, Italy, Japan, South Korea, Mexico, Netherlands,
Philippines, Poland, Portugal, Russian Fed., Sweden, Singapore, Thailand, Turkey, South Africa, Algeria, Angola,
Bahrain, Belarus, Benin, Bolivia, Bosnia-Herz., Bulgaria,
Burkina Faso, Cameroon, Cape Verde, Chad, Costa Rica,
Croatia, Dem. Rep. Congo, Dominican Rep., Dutch Antilles,
Ecuador, El Salvador, Georgia, Guatemala, Indonesia, Iran,
Iraq, Israel, Kenya, Lebanon, Lithuania, Macedonia, Mali,
Malta, Mongolia, Morocco, Mozambique, Nicaragua,
Pakistan, Panama, Paraguay, Peru, Philippines,
Qatar, Romania, Saudi Arabia, Senegal, Serbia, Slovenia,
Sril Lanka, Syria, Tunisia, Uruguay, Utd.Arab Emir.,
Vietnam, Djibouti, Equatorial Guin, Zambia, Cap Verde |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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| 510(K) Database | 510(K)s with Product Code = LKQ
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