Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported November 7, 2012
cobas 4800 BRAF V600 Mutation Test for In Vitro Diagnostic Use Roche Molecular Systems, Inc., Product Usage: The primary use of the cobas 4800 BRAF V600 Mutation Test is the detection of the BRAF V600 mutations in DNA extracted from formalin-fixed, paraffin-embedded human melanoma tissue. It is intended to be used as an aid in selecting melanoma patients whose tumors carry BRAF V600 mutations for treatment with Zelboraf (vemurafenib).
It was identified that BRAF controls dispositioned as "Internal Use Only" were incorrectly packaged into cobas 4800 BRAF V600 Mutation Test CE-IVD kit lot R03607 and released for …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Roche Molecular Systems, Inc. recalled cobas 4800 BRAF V600 Mutation Test for In Vitro Diagnostic Use Roche Molecular Systems, I… - a low-severity action.
cobas 4800 BRAF V600 Mutation Test for In Vitro Diagnostic Use Roche Molecular Systems, I… was recalled by Roche Molecular Systems, Inc. in November 7, 2012. Reason: It was identified that BRAF controls dispositioned as "Internal Use Only" were incorrectly packaged into coba…. Check the official notice for the remedy. Verify recall #Z-0188-2013 with the FDA Devices before acting.
The recall
Roche Molecular Systems, Inc. issued this low-severity FDA Devices recall-It was identified that BRAF controls dispositioned as "Internal Use Only" were incorrectly packaged into coba….
- Low
- severity level
- Class III
- classification
- November 7, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0188-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0188-2013) was formally reported on November 7, 2012, with the manufacturer initiating the action on July 31, 2012. It is classified under Low severity (Class III), with a current status of Terminated. Roche Molecular Systems, Inc. is listed as the recalling firm, operating out of Branchburg, NJ. Federal records list the affected scope as 44 kits.
The documented reason for this recall is: It was identified that BRAF controls dispositioned as "Internal Use Only" were incorrectly packaged into cobas 4800 BRAF V600 Mutation Test CE-IVD kit lot R03607 and released for distribution. Two control batches manuf… Distribution data in the federal record shows the product reached: Worldwide Distribution - Australia, Austria, Belgium, China, Hungary, Turkey and United Kingdom.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
44 kits
Related Recalls
6
3 from same agency
Product description
cobas 4800 BRAF V600 Mutation Test for In Vitro Diagnostic Use Roche Molecular Systems, Inc., Product Usage: The primary use of the cobas 4800 BRAF V600 Mutation Test is the detection of the BRAF V600 mutations in DNA extracted from formalin-fixed, paraffin-embedded human melanoma tissue. It is intended to be used as an aid in selecting melanoma patients whose tumors carry BRAF V600 mutations for treatment with Zelboraf (vemurafenib).
Reason for recall
It was identified that BRAF controls dispositioned as "Internal Use Only" were incorrectly packaged into cobas 4800 BRAF V600 Mutation Test CE-IVD kit lot R03607 and released for distribution. Two control batches manufactured during two process validation studies are involved: PV7711: BRAF Mutant (MUT) Control PV0853: BRAF Wild Type (WT) Control
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-0188-2013 |
| Date reported | November 7, 2012 |
| Date initiated | July 31, 2012 |
| Recalling firm | Roche Molecular Systems, Inc. |
| Firm location | Branchburg, NJ |
| Affected scope | 44 kits |
| Distribution | Worldwide Distribution - Australia, Austria, Belgium, China, Hungary, Turkey and United Kingdom. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0188-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
cobas 4800 BRAF V600 Mutation Test for In Vitro Diagnostic Use Roche Molecular Systems, Inc., Product Usage: The primary use of the cobas 4800 BRAF V600 Mutation Test is the detection of the BRAF V600 mutations in DNA extracted from formalin-fixed, paraffin-embedded human melanoma tissue. It is intended to be used as an aid in selecting melanoma patients whose tumors carry BRAF V600 mutations for treatment with Zelboraf (vemurafenib).. Recalled by Roche Molecular Systems, Inc.. Units affected: 44 kits.
Why was this product recalled? ▼
It was identified that BRAF controls dispositioned as "Internal Use Only" were incorrectly packaged into cobas 4800 BRAF V600 Mutation Test CE-IVD kit lot R03607 and released for distribution. Two control batches manufactured during two process validation studies are involved: PV7711: BRAF Mutant (MUT) Control PV0853: BRAF Wild Type (WT) Control
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 7, 2012. Severity: Low. Recall number: Z-0188-2013.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - Australia, Austria, Belgium, China, Hungary, Turkey and United Kingdom..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0188-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
CPSC Moderate
Rowenta Recalls Cordless Vacuum Cleaners Due to Risk of Serious Injury from Fire and Burn Hazards
· 2026-07-02
CPSC Moderate
Daikin Comfort Technologies Manufacturing Recalls Amana Air Conditioners and Heat Pumps Due to Risk of Serious Injury f…
· 2026-06-25
CPSC Moderate
Arizer Solo III Portable Vaporizers Recalled Due to Fire and Burn Hazards; Risk of Serious Injury or Death; Imported by…
· 2026-06-18
FDA Devices Moderate
GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603-902, Product Code KSA; used i…
GE Medical Systems Information Technologies Inc · 2026-06-03
FDA Devices Critical
Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) BLOCK TRAY, Medline Kit…
Medline Industries, LP · 2026-06-03
Compare this recall with Rowenta Recalls Cordless Vacuum Cleaners Due to Risk of Ser… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 7, 2012. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.