Z-1531-2026Class II
GEM Premier 5000 PAK; Part No. 00055407511
Instrumentation Laboratory Co. / initiated 2026-01-20 / Open, Classified / root cause: manufacturing process
Instrumentation Laboratory began a recall of GEM Premier 5000 PAK; Part No. 00055407511 on . FDA classified it as Class II and gives the reason as "Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including...". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-1531-2026
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Instrumentation Laboratory Co.
- Product
- GEM Premier 5000 PAK; Part No. 00055407511.
- Product code
- CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- Reason for recall
- Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
- Root cause tag
- manufacturing process
- FDA root cause
- Nonconforming Material/Component
- Action
- An URGENT MEDICAL DEVICE CORRECTION notice was sent to consignees on 1/20/26 was sent to consignees. The notice instructs consignees to continue to use affected devices with the provided warmup instructions. Consignees are to inform all laboratory staff of this notification and forward the notification if product was further distributed. A copy of the notification is to be maintained in consignee records. Consignees may contact Werfen Technical Support at 1-800-678-0710 for a replacement if a GEM PAK experiences a Process Control Solution Not Detected error.
- Quantity in commerce
- 27 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Bulgaria, Brazil, Belarus, Switzerland, Canada, Chile, China, Colombia, Czech Republic, Germany, Denmark, Dominican Republic, Ecuador, Estonia, Spain, Finland, France, United Kingdom, Georgia, Greece, Guatemala, Hong Kong, Croatia, Hungary, Indonesia, Ireland, Israel, India, Italy, Jordan, Japan, South Korea, Kazakhstan, Lebanon, Lithuania, Luxembourg, Latvia, Macau, Mexico, Malaysia, Netherlands, New Zealand, Oman, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Serbia, Saudi Arabia, Sweden, Singapore, Slovenia, San Marino, South Africa, Thailand, Tunisia, Turkey, Uruguay, Uzbekistan & Vietnam.
- Product codes and lots
- Part number: 00055407511; UDI: 08426950807643; Lots No. 251114K, 251201X, 251215D.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1524-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1525-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1526-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1527-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1528-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1529-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1530-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1531-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1532-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1533-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1534-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1535-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1536-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1537-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1538-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1539-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1540-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1541-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1542-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1543-2026 | Class II | Ongoing | Voluntary: Firm initiated |
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