cobas¿ PCR Urine Kit 100 PKT IVD cobas¿ PCR Female Swab Kit 100 PKT IVD cobas¿ PCR media 100T I...
FDA Device Recall #Z-1111-2014 — Class II — January 6, 2014
Recall Summary
| Recall Number | Z-1111-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 6, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Roche Molecular Systems, Inc. |
| Location | Branchburg, NJ |
| Product Type | Devices |
| Quantity | 84 kit batches |
Product Description
cobas¿ PCR Urine Kit 100 PKT IVD cobas¿ PCR Female Swab Kit 100 PKT IVD cobas¿ PCR media 100T IVD cobas¿ PCR Female Swab Kit 100 PKT JPN-IVD Roche Molecular Systems, Inc. Branchburg, NJ 08876 USA Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250-0457 The cobas¿¿ PCR media serves as a nucleic acid stabilizing transport and storage medium for gynecological specimens and is contained in the cobas¿¿ PCR Female Swab Kit, cobas¿¿ PCR Urine kit, and cobas¿¿ PCR media 100 T kit. -The cobas¿¿ PCR Urine Sample Kit is used to collect and transport urine specimens. Use this collection kit only with the cobas¿¿ CT/NG Test. - The cobas¿¿ PCR Female Swab Sample Kit is used to collect and transport endocervical and vaginal swab specimens. Use this collection kit only with the cobas¿¿ CT/NG Test NOTE: This collection kit should not be used for collection of female urine specimens. o For endocervical swab specimens, collections are to be performed by a clinician. o For vaginal swab specimens, collections are to be performed by a clinician or by the patient (self-collection) -In US labeling, it indicates Self collection in a clinical setting. - In ex-US labeling, it indicates Clinician Instructed Self- Collection and Ensure the patient has read and understood the following self-collection instructions before providing a collection kit. - In some countries (e.g., UK), the sample collection kit is provided as self-collection for home / personal use, which may not be used in a controlled clinical setting and it is unknown if any instructions are provided. - The cobas¿¿ PCR media kit is used to stabilize and transport urine specimens. Use this kit only with the cobas¿¿ CT/NG Test.
Reason for Recall
Numerous complaints have been filed that leaking cobas ¿ PCR media 4.3 mL IVD have been received from different lots of the cobas ¿ PCR Urine kits, cobas ¿ PCR Female Swab kits, and cobas ¿ PCR media kits.
Distribution Pattern
Nationwide Distribution
Lot / Code Information
K110923 cobas PCR Female Swab Sample Kit 05170516190 Lot S01487 and earlier cobas PCR Urine Sample Kit 05170486190 Lot S01885 and earlier (except lot number S01884) IVD: 48 kit batches US: 31 kit batches JPN-IVD:6 kit batches
Other Recalls from Roche Molecular Systems, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1104-2023 | Class II | cobas SARS-CoV-2 & Influenza A/B Qualitative as... | Dec 21, 2022 |
| Z-1106-2023 | Class II | cobas Influenza A/B & RSV UC (Utility Channel) ... | Dec 21, 2022 |
| Z-1105-2023 | Class II | cobas SARS-CoV-2 & Influenza A/B Qualitative nu... | Dec 21, 2022 |
| Z-0097-2023 | Class II | cobas 5800 instrument, Material No. 08707464001... | Sep 8, 2022 |
| Z-0828-2022 | Class II | cobas LiatSystem, respiratory virus panel nucle... | Nov 16, 2021 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.