instrumentation laboratorymedicalHigh PriorityActive

GEM Premier 5000; Part No. 00055430011.

GEM Premier 5000; Part No. 00055430011. was recalled because 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.. If you have this product, stop using it until you verify your lot or model details.

By RecallRadar Editorial Team

Sourced from FDA. Last verified April 6, 2026.

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Key facts

Date announced: March 18, 2026
Source agency: FDA

This recall involves safety concerns. Take action promptly.

✨ Plain-English Summary

Is This Recall Still Active?

Status: Yes - Active

This recall is currently active. If your device matches the affected models, follow the official instructions as soon as possible.

What's Being Recalled

Quoted source excerpt from the official notice.

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.

Quick Info

Key facts from the official notice, kept in the article flow for easy cross-checking.

Brand: Instrumentation laboratory
Category: medical
Source agency: FDA
Announced: March 18, 2026
Country: US
Status: Active

Who's Affected

Specific models and identifiers listed in the source notice:

Model #1

Part number: 00055430011; UDI: 08426950807766; Lots No.: 251114K, 251205K, 251215D.

#	Model
1	Part number: 00055430011; UDI: 08426950807766; Lots No.: 251114K, 251205K, 251215D.

Technical model codes are manufacturer identifiers. Match both the product name and model code from your device settings, label, or packaging.

What You Should Do

Follow the remedy path from the official notice using the exact model and serial details above.

1Stop using the affected product until you verify whether your item is impacted.
2Check the official recall notice and match your model, lot, or serial details.
3Follow the official instructions for repair, replacement, refund, or disposal.

Open Official Recall Notice

Source & Verification

This page summarizes the official notice and keeps key facts easy to verify.

Official source: FDA
Announced by source: March 18, 2026
Last reviewed by RecallRadar: April 6, 2026

Frequently Asked Questions

Am I affected by this recall?

Check the affected models section on this page. The official notice currently lists Part number: 00055430011; UDI: 08426950807766; Lots No.: 251114K, 251205K, 251215D..

What is the remedy for this recall?

Follow the official instructions for repair, replacement, refund, or disposal on the instrumentation laboratory recall page.

Where can I verify recall details?

Use the official source link in this page to confirm dates, eligibility, and next steps: https://api.fda.gov/device/enforcement.json?search=recall_number:Z-1540-2026&limit=1

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